Company:Baxter Healthcare Corporation
Date of Enforcement Report 4/11/2018
Class lI:
PRODUCT
Prismaflex Control Unit. Dialyzer, high permeability with or without sealed dialysate system.Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilograms or more with acute renal failure and/or fluid overload.
Recall Number Z-1280-2018
REASON
Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex Control Unit. Additionally, for software versions 5.10 and 6.10, the programmed syringe size for the syringe pump may revert to safe default values unintentionally.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corporation, Deerfield, IL on 2/15/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3,440 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
